On July 28th, the European Commission’s Directorate General for Communications Networks, Content and Technology (DG CONNECT) and the United States Department of Health and Human Services (DHHS) announced their agreement on an updated roadmap for the Memorandum of Understanding on cooperation surrounding health related information and communication technologies (the MoU).

The MoU was entered into in December 2010 to demonstrate the shared dedication of EU and US authorities in addressing challenges concerning eHealth/Health IT (‘eHealth’ being the European term for what is typically referred to as ‘Health IT’ in the US). The first roadmap of MoU actions was published in March 2013, and focused on outlining the vision, challenges and scope of two priority areas: ‘International Interoperability’ and ‘eHealth/Health IT Workforce Development’. In December 2015, DHSS and DG CONNECT agreed to add a third priority area to the MoU roadmap, namely ‘Transatlantic eHealth/Health IT Innovation Ecosystems’.

Continue Reading eHealth/Health IT Ties Between the EU and US Strengthened Following Agreement by Government Agencies on New Roadmap

On July 29, 2016, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) finalized a guidance framing its enforcement discretion policy regarding Low Risk General Wellness Devices. The Final Guidance largely tracks the draft policy issued in January 2015 (which we previously summarized), but provides more insight into FDA’s thinking, as well as additional examples of products falling within and outside the terms of FDA enforcement discretion.

Under the Final Guidance, CDRH does not intend to examine low risk “general wellness products” (as defined in the Final Guidance) to determine whether they are medical devices within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA), and if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FDCA and implementing regulations (e.g., 21 CFR Part 807 (premarket notification); 21 CFR Part 801 and 21 CFR § 809.10 (labeling); 21 CFR Part 820 (good manufacturing practices/Quality Systems); and 21 CFR Part 803 (Medical Device Reporting (MDR) requirements)).

In other words, CDRH does not intend to actively regulate products that meet the definitions in the Final Guidance, regardless of whether the product would otherwise meet the definition of a medical device under section 201(h) of the FDCA. The Final Guidance does not apply to any products regulated by FDA’s other Centers (e.g., drugs, biologics),  or to combination products.

CDRH did, however, make several clarifications in the Final Guidance and provided additional examples that may be useful for industry in assessing the regulatory status of devices, as described in greater detail below.  CDRH also announced that it will be holding a Webinar on September 1, 2016 from 12 – 1:30 pm EST to discuss the Final Guidance.

To read more about the Final Guidance, please read our Advisory.

Last week, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Dissemination of Patient-Specific Information from Devices by Device Manufacturers,” which is intended to “clarify that manufacturers may share patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with that specific device.”  Such sharing, the FDA believes, “will empower patients to be more engaged with their healthcare providers in making sound medical decisions.”

The draft guidance is timely. Individuals are increasingly using wearable mobile technologies (e.g., trackers, fitness watches, etc.), as well as mobile medical applications and related health software.  Many wearable technology manufacturers are facing increased scrutiny and litigation about the reliability of their products’ assessments (e.g., sleep or exercise trackers).  And there is considerable concern about the security of patient-specific information on such devices.

The draft guidance defines “patient-specific information” to mean “any information unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of a medical device, may be recorded, stored, processed, retrieved, and/or derived from that medical device.” Such information may include, but is not limited to:

  • recorded patient data;
  • device usage/output statistics;
  • healthcare provider inputs;
  • incidence of alarms; and/or
  • records of device malfunctions or failures.

Continue Reading Sharing is Caring: FDA Issues Draft Guidance on Device Manufacturers Sharing Patient-Specific Information from Medical Devices

In prior blogs, we’ve discussed the “team” approach being used by federal agencies to regulate consumer products. Last week, the FTC provided further evidence of the government’s collaborative spirit, through the release of a web-based tool designed to help developers of health-related mobile apps understand what federal laws and regulations might apply to their apps.

According to its press release, the FTC developed this guidance tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology, Office for Civil Rights, and the Food and Drug Administration, with consideration of the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act  and the Federal Food, Drug and Cosmetics Act.

Continue Reading Federal Agencies Collaborate to Forewarn Mobile Health App Developers of Potentially Applicable Regulations

Yesterday marks one year since President Obama, launched the $215 million Precision Medicine Initiative (“PMI”) to create new and innovative tools healthcare providers can use to tailor disease treatment and prevention to an individual’s unique characteristics.  More than 40 private and public organizations, non-profit groups, academic institutions, and government agencies gathered this week at the White House to announce plans to accelerate the PMI, focusing in large part on the goal of establishing a large national research participant cohort.  The stated mission of the PMI is:

To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.

Precision medicine is a healthcare approach that takes into account differences in individuals’ genes, environment, and lifestyle. Advances in precision medicine give healthcare professionals the tools to tailor treatment to, for example, a person’s genetic makeup, which may transform how medicine is practiced.  Although precision medicine is not currently used in the treatment of most diseases, the PMI is helping fund cross-cutting research to allow more widespread use of precision medicine.

A key element of the PMI are the Data Security Policy Principles and Framework (“Data Security Principles”), which are designed to guide organizations participating in PMI-related activities on the basic obligations of protection for personal privacy.  Developed through a broad collaborative process, the Data Security Principles  set forth the following goals for each precision medicine organization: 1) to identify the organization’s specific data security risks; 2) to protect critical infrastructure services; 3) to detect any cybersecurity event; 4) to respond to detected cybersecurity events; and 5) to recover any impairment due to a cybersecurity event.  The Data Security Principles further suggest that every data security plan should: 1) be participant-centric; 2) ensure that data security is adaptable and updatable; 3) identify risks, prescribe evaluation plans, and establish clear and transparent security protocols; 4) control data while providing adequate access; and 5) responsibly maintain data security.  Additionally, the Data Security Principles support the exchange among organizations of data security  experiences and challenges in an effort to enhance mutual education and understanding of data security risks and methods of protection.

Continue Reading The Precision Medicine Initiative: One Year After Creation

On February 12, 2016, the Food and Drug Administration (FDA) released a notice of a public workshop and request for comments. The FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is hosting a public workshop titled, ‘‘Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.’’ This workshop will provide researchers, clinicians, and other medical device industry stakeholders the opportunity to discuss how the FDA can better harness data from sources of “real world” evidence from medical devices, in order to improve the safety and effectiveness of these devices.

This notice states that currently evidence is being collected in a manner that is both high-cost and inefficient. In addition, the current limitations of postmarket surveillance tools creates a disincentive for researchers to study new technologies in the United States. This symposium will examine the potential development of a national evaluation system for medical devices that would help the FDA “strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period.”

In 2015, the FDA’s Center for Devices and Radiological Health developed the foundation for a national evaluation system for medical devices. Two multi-stakeholder groups issued reports that provide recommendations on furthering the establishment of this system.

The public workshop will take place at the University of Maryland School of Pharmacy on Thursday, March 24, 2016 from 8:30 a.m. to 4:30 p.m.

Registration is available here.

Electronic comments can be submitted in the Federal eRulemaking Portal: http://www.regulations.gov.

On February 25, the Food and Drug Administration (FDA) will hold a public workshop on Next Generation Sequencing (NGS)-Based Oncology Panels, a highly anticipated program given the recent announcement of a “Cancer Moon Shot” spearheaded by Vice President Biden. FDA recently released a discussion paper for the workshop that hints at the role cloud-based computing and “big data” could play in FDA’s regulatory framework for laboratory-developed tests (LDTs).

In December, FDA launched precisionFDA, a “secure, cloud-based platform where participants can access and share datasets, analysis pipelines, and bioinformatics tools” (previously described on this blog.) The agency has published white papers on the analytical and clinical validation of NGS testing that explore “the potential use of databases as sources of clinical evidence in support of regulatory submissions” that could be used for NGS as well as for “any genetic test” (that is, any of the roughly 60,000 LDTs in use today.)

Continue Reading FDA Hints at a Compromise on Regulation of Next-Generation Sequencing Tests and Other Lab-Developed Tests

Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the agency’s recommendations for Postmarket Management of Cybersecurity in Medical Devices.  The guidance is applicable to medical devices that contain software (including firmware) or programmable logic, as well as software that meets the definition of a medical device.  The guidance does not apply to experimental or investigational medical devices.  Comments on the draft guidance are due by April 21, 2016.

The draft guidance emphasizes that manufacturers should proactively monitor, identify and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices.  FDA defines “vulnerability” as a “weakness in an information system, system security procedures, internal controls, or implementation that could be exploited by a threat.”  The draft guidance defines “exploit” to mean “an instance where a vulnerability or vulnerabilities have been exercised (accidently or intentionally) and could impact the essential clinical performance of a medical device or use a medical device as a vector to compromise the performance of a connected device or system.”

The draft guidance explains that for a small subset of cybersecurity vulnerabilities and exploits that may compromise “the essential clinical performance of a device and present a reasonable probability of serious adverse health consequences or death,” the FDA would require medical device manufacturers to notify the agency under 21 CFR 806.10.  This section generally requires device manufacturers to notify FDA in writing within 10-working days of any correction (e.g., repair, modification, adjustment, relabeling) or removal of a device that was initiated to (1) reduce a risk to health posed by the device; or (2) remedy a legal/regulatory violation caused by the device that may present a risk to health.  FDA’s guidance defines “essential clinical performance” to mean “performance that is necessary to achieve freedom from unacceptable clinical risk[], as defined by the manufacturer.”  Thus, FDA explained that manufacturers should “define, as part of risk management, the essential clinical performance of their device, the resulting severity outcomes if compromised, and the risk acceptance criteria,” taking into consideration the requirements necessary to achieve device safety and effectiveness.

Further, the guidance recommends that the process to assess the cybersecurity risk to a device’s essential clinical performance should consider: (1) the exploitability of the cybersecurity vulnerability; and (2) the severity of the health impact to patients if the vulnerability were to be exploited.  The guidance also recommends that manufacturers evaluate whether the risk to essential clinical performance of the device is controlled (acceptable) or uncontrolled (unacceptable).  In one example, FDA explained that a manufacturer would be required to notify FDA under 21 CFR 806.10 under the following circumstances:

A manufacturer becomes aware of a vulnerability via a researcher that its Class III medical device (e.g., implantable defibrillator, pacemaker, etc.) can be reprogrammed by an unauthorized user.  If exploited, the vulnerability could result in permanent impairment, a life-threatening injury, or death.  The manufacturer is not aware that the vulnerability has been exploited and determines that the vulnerability is related to a hardcoded password, and cannot be mitigated by the device’s design controls.  The risk assessment concludes that the exploitability of the vulnerability is moderate and the risk to the device’s essential clinical performance is uncontrolled.  The manufacturer notifies appropriate stakeholders, and distributes a validated emergency patch.

A hospital reports that a patient was harmed after a medical device failed to perform as intended.  A manufacturer investigation determines that the medical device malfunctioned as a result of exploitation of a previously unknown vulnerability in its proprietary software.  The outcome of the manufacturer’s investigation and impact assessment determines that the exploit indirectly impacts the device’s essential clinical performance and may have contributed to a patient death.  The manufacturer notifies the customer base and user community, and develops a validated emergency patch within 30 days of learning of the vulnerability.  … Because there has been a serious adverse event or death associated with the vulnerability, the manufacturer files a report in accordance with 21 CFR 806.10 to notify FDA and complies with reporting requirements under 21 CFR part 803.

Conversely, for the majority of cases, FDA explains that actions taken by manufacturers to address cybersecurity vulnerabilities and exploits are considered “cybersecurity routine updates or patches,” for which the FDA does not require advance notification or reporting under 21 CFR part 806.  The draft guidance defines “cybersecurity routine updates or patches” to mean:

updates or patches to a device to increase device security and/or remediate vulnerabilities associated with controlled risk and not to reduce a risk to health or correct a violation of the FD&C Act.  They include any regularly scheduled security updates or patches to a device, including upgrades to the software, firmware, programmable logic, hardware, or security of a device to increase device security as well as updates or patches to address vulnerabilities associated with controlled risk performed earlier than their regularly scheduled deployment cycle even if they are distributed to multiple units. Cybersecurity routine updates and patches are generally considered to be a type of device enhancement that may be applied to vulnerabilities associated with controlled risk and is not considered a repair.  Cybersecurity routine updates and patches may also include changes to product labeling, including the instructions for use, to strengthen cybersecurity through increased end-user education and use of best practices.

For example, FDA explained that a manufacturer would not be required to notify FDA under 21 CFR 806.10 under the following circumstances:

A device manufacturer receives a user complaint that a recent security software scan of the PC component of a Class III medical device has indicated that the PC is infected with malware.  The outcome of a manufacturer investigation and impact assessment confirms the presence of malware and that the primary purpose of the malware is to collect internet browsing information.  The manufacturer also determined that the malware has actively collected browsing information, but that the device’s essential clinical performance is not impacted by such collection.  The manufacturer’s risk assessment determines that the risk due to the vulnerability is controlled.  Since essential clinical performance was not impacted, the manufacturer can update the product and it will be considered a cybersecurity routine update or patch. … Because the device is a Class III device, the manufacturer should report the changes to the FDA in its periodic (annual) report required for holders of an approved PMA under 21 CFR 814.84.

The draft guidance goes on to explain that it is essential that manufacturers implement comprehensive cybersecurity risk management programs and documentation consistent with the Quality System Regulation (21 CFR part 820), including but not limited to complaint handling (21 CFR 820.198), quality audit (21 CFR 820.22), corrective and preventive action (21 CFR 820.100), software validation and risk analysis (21 CFR 820.30(g)) and servicing (21 CFR 820.200).  The draft guidance explains that such programs should emphasize addressing vulnerabilities which may permit the unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient, and may impact patient safety.  FDA recommends that critical components of such a program should include:

  • Monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities and risk;
  • Understanding, assessing and detecting presence and impact of a vulnerability;
  • Establishing and communicating processes for vulnerability intake and handling;
  • Clearly defining essential clinical performance to develop mitigations that protect, respond and recover from the cybersecurity risk;
  • Adopting a coordinated vulnerability disclosure policy and practice; and
  • Deploying mitigations that address cybersecurity risk early and prior to exploitation

FDA’s new draft guidance outlines in greater detail each of the recommendations and considerations manufacturers should incorporate into their postmarket cybersecurity risk management programs.

The draft guidance comes roughly one month after FDA announced that it would be convening a workshop on device cybersecurity on January 20-21, 2016, for which FDA also released supporting materials.

The draft guidance also comes several months after FDA issued what appeared to be its first public Safety Communication about cybersecurity vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems.  The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) also included in its 2016 Work Plan examining FDA’s oversight of hospitals’ networked medical devices and their cybersecurity.

Prior to this draft guidance, FDA issued guidance on the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which outlines when manufacturers should consider cybersecurity during the design phases of the medical device lifecycle.  FDA’s new draft postmarket guidance reiterates that manufacturers address cybersecurity “throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device.”  Further, FDA recognized that the issuance of its new draft guidance is consistent with Executive Order 13636 – Improving Critical Infrastructure Cybersecurity, issued by the President in February 2013, which emphasizes the need for stakeholders in the Healthcare and Public Health Critical Infrastructure Sector to enhance cybersecurity measures.

As we enter this new era of medical device cybersecurity, it will be incumbent upon medical device manufacturers and related stakeholders to assess FDA’s recent guidance and begin evaluating necessary changes and enhancements.

On December 18, 2015, President Obama signed a $1.1 trillion Omnibus spending bill. Among many other things in its 2,009 pages, the bill mandates the creation of a Healthcare Industry Cybersecurity Task Force. The Task Force must be established within 90 days of the bill’s enactment, which is March 17, 2016. Given the fact that the healthcare industry is increasingly a target to hackers, the creation of the task force should be welcome news.

Many, including the Washington Post, dub 2015 as “the year of the health-care hack.” While it is believed that there were over 730 data breaches this year, the seven largest hacks exposed personal records and data corresponding to roughly 193 million people. Over one-third of the breaches — 259 — occurred in the health care sector. Three of the seven largest breaches pertained to covered healthcare entities with large amounts of Americans’ protected health information. Healthcare data hacks are particularly troublesome given the sensitivity of the stolen data. Health data often involves highly personal and private information, including data pertaining to children and minors. Individuals whose medical information has been stolen can be at increased risk for identity theft and medical fraud, causing them not only financial harm, but potentially physical harm as well.

Section 405(c) of the bill requires the Secretary of Health and Human Services (“HHS”) to convene the Task Force in consultation with the Director of National Institutes of Standards and Technology (“NIST”) and the Secretary of Homeland Security (“DHS”). The Task Force will include healthcare industry stakeholders, cybersecurity experts, and any Federal agencies or entities the Secretary deems appropriate to include. In accordance with the bill’s instructions, the Task Force will operate for one year following its creation.

Continue Reading Congress Directs HHS to Convene a Cybersecurity Task Force

On December 18, Congress passed and President Obama signed into law a bipartisan budget agreement for federal fiscal year 2016. A package of Medicare changes was included, notably addressing the Meaningful Use penalties facing physicians and other healthcare professionals who bill Medicare (so-called eligible professionals or EPs) under the Electronic Health Record (EHR) Incentive Program.  Under that program’s rules, EPs and hospitals that do not meet Centers for Medicare and Medicaid Services (CMS) requirements for Meaningful Use in 2015 will see their Medicare Physician Fee Schedule payments reduced by 1 percent in 2017.

On October 16, 2015, CMS released a final rule modifying the program’s rules for 2015 through 2017 — the “Modified Stage 2” rules — and final rules for Stage 3.  The rules permit providers who were previously scheduled to be in a Stage 1 EHR reporting period for 2015 to use a lower threshold for certain measures.  Concerns about the ability to meet the Stage 3 requirements drove the push for passage of S. 2425.

The changes to the Meaningful Use requirements in S. 2425 were sponsored by Sen. Rob Portman (R-OH) and Sen. Bob Casey (D-PA).  According to a summary provided by the bill’s sponsors, “an increase in the submission of hardship applications from [meaningful use] requirements in effect for 2015 is expected for reasons beyond providers’ control.”

Continue Reading Congress Provides Relief from Meaningful Use Penalties, With Some Strings Attached